Principal Scientist, LNP Drug Product Characterization (Biophysics and Analytics) - Vaccines

Job title : Principal Scientist, LNP Drug Product Characterization (Biophysics and Analytical) - Vaccines

Location: Waltham, MA

In the race for the future of health The Sanofi mRNA Center of Excellence (CoE)

At Sanofi, we chase the miracles of science, and we know mRNA has a role to play in the future of health. And while the pandemic has shaken up our industry, creating new opportunities and risks, we believe the acceleration of innovation with mRNA technology means vaccines and treatments for more people faster than before.

Thats why were looking for bold, optimistic world-changers to join our mRNA Center of Excellence. Were investing 400m a year into the new Center, hiring a team of 450 dedicated employees, and focusing on implementing an integrated end-to-end mRNA vaccine capabilities and research with R&D, digital and CMC teams.

Bring your ambition and optimism and join us on our journey to discover and deliver transformative medicine to patients through the advancement of our cutting-edge mRNA technology!

As the Principal Scientist within the Drug Product Platform and Early Clinical Development Team, you will provide hands-on leadership to a small team focusing on LNP analytics to characterize LNP Drug Products. The Principal Scientist will be responsible for method transfer of core LNP characterization methods from Analytical Sciences, establishing and training team, and building strong relationships with Analytical Science, and Lab Team Leaders/Unit Heads within the DP Development team to ensure robust analytical results are generated to help drive LNP formulation and process development initiatives. The Principal Scientist will need a deep scientific understanding of biophysical characterization methods, and the use of chromatographic and spectroscopic techniques to support the development of new LNP formulations for the CMC team in the mRNA Center of Excellence with the ultimate goal of to contribute to Sanofis goals of bringing innovative new mRNA vaccines to the market. This role will work across multiple teams and functions (CMC Drug Product Development, Analytical Science, Research Formulation and Delivery, and CMC Regulatory) and potentially different stages of drug product development to seek innovation in biophysics-related characterization and support project development, including troubleshooting and automation.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities:

• Build/Lead a team (1-2 contractors) to meet the biophysical characterization and analytical needs of the DP Platform and Early Clinical Development Team.

• Act as the teams liaison to Analytical Science and build strong working relationships with key stakeholders to ensure methods are fully aligned between the two teams and swiftly implement necessary changes/improvements.

• Develop a robust sample testing strategy, including sample tracking, data reporting, and iLab integration.

• Represent Drug Product Platform and Early Clinical Development team and collaborate cross-functionally in the design, development, and execution of biophysical characterization studies to enable the development of a new LNP platform.

• Supervise and mentor junior scientists for LNP drug product characterizations and manage the operation of analytical requests within the Platform and Early Clinical Development team.

• Provide scientific insights through the lens of biophysical science (particle size measurement, zeta potential determination, particle morphology, internal structure determination, lipid fluidity, and nucleic acid-lipid interaction), and chromatography analysis to support the development of new-generation LNP vaccines, including considering the vaccines' thermostability, potency, and manufacturing process.

• Support the technology transfer of drug product formulation and process to toxicology batch and pilot scale as needed.

• Represent function in cross-functional and strategic teams engaged in novel mRNA vaccine development.

• Analyze, interpret, and summarize results in technical reports and presentations.

• Stay current with the literature on biophysical characterization and analytical techniques related to lipid nanoparticles and provide management with related equipment recommendations.

• Provides training, technical oversight, and strategic guidance to junior team members.

The duties of this role are conducted in a lab environment. Experience with electronic record keeping and data software, like electronic lab notebooks, EndNote, maintenance of laboratory instrumentation (organizing preventative maintenance, data backup, software upgrade, etc.), as well as GraphPad, Visio, JMP/Minitab, and Adobe Pro, would be an advantage.

About You

• Earned Ph.D. in Biophysics, Physics, Chemical Engineering, Pharmaceutical Science, Chemistry or related sciences with 3+ years of relevant post-doc or/and industry experience.

• Analytical and formulation knowledge of nucleic acids, lipid biochemistry, formulation stability, and biotherapeutic drug product process development is essential.

• Strong preference for experience and knowledge in biophysics and advanced biophysical characterization of lipid nanoparticles or other lipid-based nanoparticle drug delivery systems.

• Experience reading and interpreting scientific data, as well as oversight of the collection and storage of data is highly preferred.

• Firsthand experience in analytical tools, such as SEC, FFF-MALS, DLS, HPLC, RP-IP, AEX, AUC, microscopy, particle size tracking, and MFI, is preferred.

• Experience in studies/data interpretation of Isothermal calorimetry, SAXS, SANS, and NMR is desirable.

• Experience in fluorescence microscopy, single particle tracking, and quartz crystal microbalance with dissipation (QCM-D) is a plus.

• Hands-on experience with lipid-based nanoparticle systems and mRNA-based product development is highly desirable.

• Experience leading teams, mentoring others, training or other leadership roles is ideal.

• Desire to work in a fast-paced environment.

• Excellent organizational and communication skills

• Strong analytical and problem-solving skills

• A strong ability to communicate scientific topics in writing and presentations.

• The individual must work in a collaborative setting, and the ability to adhere to timelines is essential.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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Better is out there. Better medications, better outcomes, better science. But progress doesnt happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, lets be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

North America Applicants Only

The salary range for this position is:

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK .